Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- HbA1c after HCL
研究概览
简要总结
The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.
详细描述
Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.
For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.
Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.
At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 15 and 25 years old
- •Type 1 diabetes since at least 1 year at the moment of instauring HCL
- •At least 3 months of HCL use
排除标准
- •Informed patient that have been opposed for their data collect
结局指标
主要结局
HbA1c after HCL
时间窗: at 3 months
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
次要结局
- nephropathy(at 3 months)
- Use of HCL(at 3 months)
- Glycemic parameters with CGM(at 3 months)
- keto-acidosis and severe hypoglycemia(at 3 months)
- retinopathy(at 3 months)
- HbA1c after HCL(at 24 months)
- HCL stop(at 3 months)